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EU 2017 Podcast: New Regulations Imminent But Much Regulatory Uncertainty Too

Now that 2017 has begun, what stage have the EU medtech regulations reached and what issues are going to most concern the medtech sector this year? Ashley Yeo, principal analyst and health-care editor at In Vivo, interviewed Medtech Insight's regulatory affairs specialist Amanda Maxwell to pinpoint the topics that industry needs to follow most closely.

Medical Device Regulation Europe

Abbott's Robert Ford: Device Chief Looks Ahead After St. Jude Deal

In an interview with Medtech Insight at this year's JP Morgan Healthcare Conference, the executive VP of medical devices for Abbott Laboratories discussed the firm's recent mega-acquisition of St. Jude Medical, the opportunity in cardiovascular, value-based business models, cybersecurity, and more.

Commercial Medical Device Deals

GE Healthcare Extends Portfolio With First App-Based Ultrasound Device

GE Healthcare has unveiled a new handheld ultrasound device with wireless capabilities. The Vscan Extend is the company's first app-based ultrasound device to integrate with hospital DICOM systems and used in rural environments.

Diagnostic Imaging Innovation Research & Development

Podcast: AdvaMed Gears Up For 2017

In an exclusive podcast interview with Medtech Insight, AdvaMed's top lobbyist speaks about the group's aspirations for 2017, a new administration and hope to continue the cultural shift already in the works at FDA.

Legislation FDA US Election 2016
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Policy & Regulation Explore this Topic

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New PIP Court Ruling Sends Further Shockwaves Through EU Medtech Sector

Notified bodies in the EU medtech sector have reason to feel nervous: recipients of the fraudulently manufactured PIP breast implants have had yet more court success in a case that is challenging the liability status of notified bodies at a critical time for EU regulation. But the final say is still awaited.

Medical Device Policy & Regulation Europe

FDA's Document Dump: Guidance Release Skyrocketed In Advance Of Trump

Uncertainty about US FDA's direction under the new president may have spurred staff to ensure views on several issues released before administration changed.

Regulation Medical Device Policy

House Panel Maps Out Plan For Cures Oversight, Obamacare Repeal

The House Energy and Commerce has released its two-year oversight plans in advance of an organizational meeting. The plan features close attention to federal implementation of the 21st Century Cures Act, the efficiency of FDA product reviews, and work to repeal and replace the Affordable Care Act.

Policy Legislation

Industry 'Encouraged' By Trump Exec Order To Undo ACA, Device Tax

Industry cheered one of President Trump's first executive orders filed Jan. 20, calling on HHS and others in the executive branch to "waive, defer, grant exemptions" from Affordable Care Act provisions for industry imposing burdens on them, including the costs of taxes and fees on "makers of medical devices."

Policy & Regulation Legislation

Burwell Cautions Against Changing FDA Standards, Recommends Cybersecurity Investment

As one potential candidate for FDA commissioner has called for dismissing efficacy requirements to approve products, Burwell, soon before relinquishing her role as HHS secretary, told reporters that safety trials are insufficient to prove true safety and that her successor at HHS should prioritize cybersecurity.

Policy & Regulation US Election 2016

Trump Takes Office, Change At US FDA Arrives With ‘Beachhead Teams’

Incoming president will not hold over any FDA political appointees from the Obama administration, but what exactly his stamp on the agency will be remains unclear.

FDA US Election 2016

Compliance Corner: Have Tech-Savvy People In Place For 'Live' FDA Inspections

Device manufacturers should have appropriately skilled individuals fetching and handling electronic information to be handed over to US FDA investigators, says a former Johnson & Johnson quality & compliance expert. "The inspectional front room has to be able to manage live information, which means you have to have people who know the IT tools and how to navigate them, and how to find things quickly and explain them," Teresa Gorecki advises.

Quality Control Policy & Regulation

FDA Cracks Open Door For More Manufacturer Communications

Two draft guidance documents would allow a broader range of communications with payers and others about information not included on device labeling, or concerning products without FDA approval.

Regulation Post Market Regulation & Studies

Commercial Explore this Topic

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J&J Taps Aspect Biosystem's 3D Printing Tech For Meniscus Implant

3D bioprinting and tissue engineering specialist Aspect Biosystems has entered a research collaboration with Johnson & Johnson's DePuy Synthes to create bioprinted knee meniscus tissue suitable for surgical therapy. It is one of more than 50 commercial and academic partnerships J&J has entered to develop complementary technologies and materials for its medical devices.

Orthopedics Innovation Deals

Latest From Commercial

Atlas Genetics Fundraising Pulls In New Chinese Investment

Atlas Genetics, a UK point-of-care molecular diagnostics developer, has raised $35m in Series D financing from an investor syndicate. The funding round attracted existing shareholders and new investment from Chinese in vitro diagnostic company Wondfo Biotech.

Commercial Companies

Appeals Court Rejects False Claims Approach To FDA Off-Label Cases

A ruling from the First Circuit suggests that plaintiffs can’t prove manufacturers violated the False Claims Act by suggesting FDA submissions were fraudulent, if FDA itself hasn’t taken any action against the manufacturer.

Legal Issues Government Payers

US Sales Of Sinclair Pharma's Silhouette InstaLift-Off

Aesthetics company Sinclair Pharma has reported headline growth of 51% in 2016 due to strong unexpected interest for its Silhouette Instalift product.

Aesthetics Sales & Earnings

Zimmer Biomet To Settle Overseas Bribery Charges With US DOJ

The orthopedic device company is set to pay $17.4m to the US Department of Justice and an additional $13m to the Securities and Exchange Commission to resolve allegations that Biomet didn’t stop corrupt acts in Brazil and Mexico even after a 2012 deferred prosecution agreement.

Legal Issues Medical Device

Full Steam Ahead On Medtech Value-Based Business Models

Federal health-care policy in the US, at least, is potentially in for a major transition, but that is not having much of an impact on the fundamental business models of medtech firms and their ever-accelerating focus on value-based and risk-sharing business models. Emphasis on value strategies was a significant medtech theme at this year's JP Morgan Healthcare Conference bonanza.

Commercial Reimbursement

IBM Digs Deeper Roots In Medtech, As AdvaMed Builds Digital Footprint

IBM is getting more heavily invested in the medical device industry, announcing two major partnerships this week with diagnostic-maker Illumina and US FDA. The move is part of a larger industry trend of tech firms becoming more active in the medtech sector, and AdvaMed is adjusting to the new context.

Business Strategies Commercial

Clinical R&D Explore this Topic

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Infographic: 2016 Medical Device Approvals

Here's a graphical look at the global device approvals in 2016. It was another record year for novel devices in the US, while trends remained relatively steady in other regions.

Approvals Research & Development Medical Device

Latest From Research & Development

Abionic's New POC Sepsis Test On Rapid Move To Market

Swiss start-up Abionic has CE marked rapid tests for sepsis and iron deficiency, designed to run on its diagnostics platform abioSCOPE. The new sepsis test is based on a new biomarker PSP which has shown to be superior to current tests in detecting this life threatening condition early.

In Vitro Diagnostics Approvals

Philips Shooting For Spine Surgery Top Spot With Augmented Reality Tech

Philips is developing what it claims to be the first augmented reality surgical navigation technology that enables surgeons to view a patient's external and internal anatomy in real time during minimally invasive spine surgery. The Dutch group believes this technology could earn it a top spot in the spine surgery market.

Surgical Procedures Innovation

OUS Approvals Analysis: Slow Finish To 2016, But Still Ahead Of 2015

2016 finished with just two more non-US medical device approvals than 2015; December was by far the slowest month of the year for approvals from outside the US with just 11.

Approvals Europe

US Approvals Analysis: 2016 Another Record Year For FDA Novel Device Approvals

The agency approved a total of 91 original PMAs, panel-track PMA supplements and de novo classifications in 2016, outpacing last year's record for approvals of novel devices or indications, according to Medtech Insight's Approvals Tracker. Medtronic topped both the novel device approvals and 510(k) clearance lists for the year. Roche, Abbott, Siemens and GE also showed strong approval and clearance counts.

Approvals Research & Development

First TAVR Filter Gets US FDA Panel Date

Claret Medical’s Sentinel CPS missed its primary endpoint during a pivotal trial but showed greater benefits for patients receiving Sapien XT valves, and affirmed that it trapped debris and had a clinical benefit.

Cardiovascular Policy & Regulation

Starts & Stops: S-ICD And Respiratory App Studies Among Year-End Large-Scale Trial Launches

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions over the past month. This edition notes the particularly high number of large-scale trials launched toward the end of 2016.

Clinical Trials Research & Development
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